Agency classClass IIOur severity:High FDA (Devices)·Z-1726-2024·Announced 2024-05-08

Zimmer Distal Lateral Fibular Plates May Have Improper Screw Locking

A thread form defect in the locking holes of Zimmer surgical bone plates may prevent locking screws from securing properly, potentially causing loss of fixation during surgery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device with a manufacturing defect affecting a critical functional component (screw locking mechanism). While no illnesses or injuries have been reported, the defect poses a potential risk of loss of fixation during surgery, which could necessitate further surgical intervention. This qualifies as a high-risk product where injury has not yet been reported.

Plain-English summary

Zimmer, Inc. is recalling ZPLP Distal Lateral Fibular Plates, Left, 4 Holes, 80 MM (Item Number 00-2357-018-04), used in orthopedic surgery for temporary internal fixation and stabilization of bone fractures and osteotomies.

The recalled plates have a thread form defect in their locking holes that may prevent the locking screws from properly mating with the plate. The defect may not be readily recognizable during surgery, as the improperly secured screw may not obviously fail to lock.

This defect may result in loss of fixation or may necessitate delay in surgery or further surgical intervention. The recalled plates were distributed worldwide, including throughout the United States and in Brazil, Canada, China, Hong Kong, India, Japan, New Zealand, South Korea, Singapore, Switzerland, and Taiwan.

The recalled product

Product: ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Item Number: 00-2357-018-04
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Surgical Fixation
Hazard: loss-of-fixation
improper-locking
thread-defect

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 21 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 21 products in this recall →

Same manufacturer · Zimmer, Inc.

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Same hazard · loss of fixation